Kornimate/medical-research-clean huggingface dataset:
comparing conscious sedation to retrobulbar block anesthetics during trans-scleral diode laser

Conditions: Glaucoma

Summary: this is a non-inferiority trial with a prospective randomized controlled design assessing patient satisfaction and complications associated with both retrobulbar block anesthetics (current gold standard) and conscious iv sedation alone (alternative choice of anesthesia) for trans-scleral diode laser (tsd). patient satisfaction and complications will be measured using standardized patient surveys.

this is a non-inferiority trial with a prospective randomized controlled design assessing patient satisfaction and complications associated with both retrobulbar block anesthetics (current gold standard) and conscious iv sedation alone (alternative choice of anesthesia) for trans-scleral diode laser (tsd). patient satisfaction and complications will be measured using standardized patient surveys. methodology: 1. patients undergoing tsd would be recruited from one glaucoma subspecialist's practice. 2. patient consents to tsd at the eye clinic. 3. clinical trial is mentioned to the patient and if there is interest a consent form is given to the patient to look over and develop questions the patient may want to ask. 4. pre-anesthesia consult will be conducted to determine eligibility for both conscious sedation and retrobulbar block. 5. patient is contacted by phone by the study coordinator to discuss whether the patient is still eligible to be a part of the clinical trial and whether the patient is still interested and if yes, what questions the patient might have. if the patient wishes to meet in person this will be arranged and consent can be obtained at that time, but if the patients are from a far distance then the signing of the consent will happen on the day of the procedure (although the discussion would already have taken place over the phone). 6. patients will be randomized to either conscious sedation group, or retrobulbar injection group (control) via an online program. 7. on the day of the surgery, patients will receive a pre-anesthesia questionnaire (questions include basic identifying, health and surgery information). 8. patients will receive a post-surgery questionnaire one hour after the surgery, in the recovery room. 9. patients will receive a phone call for a post-recovery questionnaire 24 hours later. 10. patients will receive a recovery and complications questionnaire one week later at the clinic (during check-up).

Eligibility criteria:
inclusion criteria: * ability to consent * eligibility for both a conscious sedation and a retrobulbar block (decided through pre-anesthesia consult, which is a standard consult obtained for this procedure) exclusion criteria: * pregnancy * inability to consent * under 18 years of age * not eligible for conscious sedation and/or retrobulbar block.
a study of two anti-hiv drug combinations in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to compare the safety and effectiveness of giving hiv-infected patients delavirdine (dlv) plus zidovudine (zdv) plus 2 doses of indinavir (idv) or zdv plus idv plus lamivudine (3tc). this study also examines how the body processes dlv when it is given in combination with other drugs.

in this multicenter, open-label study, 45 hiv-1-positive patients receive either combination drug therapy with delavirdine (dlv), zidovudine (zdv), and indinavir (idv) or combination drug therapy with zdv, lamivudine (3tc), and idv. note: patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if hiv-1 rna is less than 5,000 copies/ml or at the investigator's discretion.

Eligibility criteria:
inclusion criteria patients must have: * hiv-1 positive. * cd4 count above 50. * hiv-1 rna greater than 20,000. prior medication: allowed: less than 1 month prior treatment with zidovudine. exclusion criteria prior medication: excluded: * prior 3tc, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. * prior zdv of greater than 1 month total duration. prior treatment: excluded: * lamivudine. * protease inhibitors. * non-nucleoside reverse transcriptase inhibitors.

Keywords: hiv-1 drug therapy, combination zidovudine hiv protease inhibitors lamivudine indinavir rna, viral delavirdine reverse transcriptase inhibitors
comparison of efficacy of indacaterol versus placebo over 12 weeks

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this 12-week study evaluated the efficacy and safety of indacaterol versus placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2008) and: 1. smoking history of at least 10 pack-years 2. post-bronchodilator fev1 \<80% and ≥30% of the predicted normal value 3. post-bronchodilator fev1/fvc (forced vital capacity) \<70% exclusion criteria: * patients who have had a copd exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd indacaterol
orthorexia nervosa in fibromyalgia

Conditions: Fibromyalgia

Summary: this clinical cross-sectional study will include 84 female patients aged between 18 and 65 years who have been diagnosed with fibromyalgia syndrome according to the 2010 american college of rheumatology diagnostic criteria. sociodemographic data will be recorded at the beginning of the study. pain severity will be assessed using the visual analog scale (vas). orthorexia nervosa-related symptoms will be evaluated with the orto-11 scale. body image will be assessed with the body appreciation scale 2, mood will be evaluated using the hospital anxiety and depression scale (hads), and fibromyalgia-related impact will be assessed with the fibromyalgia impact questionnaire (fiq).


Eligibility criteria:
inclusion criteria: * female patients aged 18-65 years. * diagnosis of fibromyalgia syndrome according to the 2010 american college of rheumatology diagnostic criteria. * willingness to participate and provision of written informed consent. exclusion criteria: * refusal to participate. * presence of diagnosed psychiatric disorders. * presence of cognitive impairment. * use of medications that may affect mood.
mitoq for fatigue in multiple sclerosis

Conditions: Multiple Sclerosis; Fatigue

Summary: the purpose of this study is to determine whether ms patients who receive oral mitoquinone (mitoq) have less fatigue than those receiving a placebo. a comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after study drug initiation will assess if mitoq has a significant change in fatigue.

mitoq is a potent antioxidant with potentially significant immunomodulatory and anti-inflammatory properties. while the cause of ms related fatigue is uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal energy depletion may be an important contributor to fatigue in ms. this clinical trial will evaluate the potential beneficial effects of mitoq on ms fatigue. it will also explore the effects of mitoq on cognitive function, quality of life and mood. if enrolled in the study, patients will take two capsules of the study drug or placebo at the same time every day for twelve weeks. there will be 4 study visits where the participant will undergo medical and nervous system examinations, questionnaires, and blood draws. because it is a placebo-controlled trial, participants will have a 33% chance of receiving either placebo (inactive), 20mg of mitoq, or 40mg of mitoq. this will be a blinded randomized study, meaning neither the participant nor the investigator will know who received the placebo or study drug.

Eligibility criteria:
inclusion criteria: * ms (any clinical subtype) as diagnosed by the 2010 mcdonald criteria40; * expanded disability status scale (edss) score of 2 to 8, * complaint of fatigue that has been persistent for at least two months; * modified fatigue impact scale (mfis) score of 38 or greater exclusion criteria: * treatment with systemic glucocorticoids in the prior six weeks; * beck depression inventory (bdi) \>31 (severe depression); * significant ms exacerbation in prior 30 days; * previous use of mitoq or coq-10 within 30 days of screening appointment; * use of non-research-pharmacy-administered mitoq or coq-10 during the duration of the study; * other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events), * pregnancy or intending to become pregnant or breastfeeding; * unable to complete the self-report forms; * unable to give informed consent; * prisoners will be excluded. * any condition which would make the patient, in the opinion of the investigator, unsuitable for the study.

Keywords: mitoquinone fatigue multiple sclerosis
exhaled breath condensate (ebc) assessment in acute exacerbation of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study aimed to assess airway inflammation in patients during the course of acute exacerbations of chronic obstructive pulmonary disease (aecopd) by serial analyses of their exhaled breath condensates (ebc).

subject recruitment patients who had been admitted to the prince of wales hospital with aecopd were recruited for this study. subjects with pneumonic changes on the chest radiographs were excluded. age and sex-matched copd subjects at stable state (without aecopd for at least 10 weeks) and healthy, non-smoking subjects were recruited as controls. collection of exhaled breath condensate (ebc) ebc was collected using the ecoscreen (viasys healthcare, conshohochen, pa, usa) according to the manufacturer's instructions. ebc was stored in 250 microl aliquots immediately at -70oc until analysis. ebc was collected on day 5, 14, 30 and 60 after hospitalization for subjects with aecopd. for the stable copd patients and normal controls, ebc collection was performed once. measurement of tnf alpha, ltb4 and il-8 the concentrations of tnf alpha, ltb4, and il-8 in ebc were measured in one batch by high-sensitivity sandwich enzyme immunoassays (tnf alpha and il-8 from biosource international, camarillo, ca, usa; ltb4 from cayman chemical company, ann arbor, mi, usa) according to the manufacturers' instructions. intra-subject repeatability of tnf alpha, ltb4 and il-8 was assessed by collection of ebc in stable copd subjects. ebc was collected as described above at the same time (09:00 to 10:00) on 2 consecutive days.

Eligibility criteria:
inclusion criteria: * patients who had been admitted to the prince of wales hospital with aecopd were recruited for this study. aecopd was defined when a patient with background copd according to the gold guideline presented with at least two of the following major symptoms (increased dyspnoea, increased sputum purulence, increased sputum volume) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days. * age and sex-matched copd subjects at stable state (without aecopd for at least 10 weeks) and healthy, non-smoking subjects were recruited as controls. current smokers (defined as cigarette smoking in the last 6 months) were excluded from this study. exclusion criteria: * subjects with pneumonic changes on the chest radiographs were excluded. * current smokers (defined as cigarette smoking in the last 6 months) were excluded from this study.

Keywords: copd exhaled breath condenate exhaled breath condenate, acute exacerbation of copd
predicting long-term outcomes after cardiac arrest by using serum ngal

Conditions: Out-of-Hospital Cardiac Arrest

Summary: this study was performed to determine the prognosis of patients after cardiac arrest using serum markers called ngal. the initial ngal values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.

serum ngal is currently being used as a test to determine the likelihood of developing renal failure. however, in a previous study, serum ngal correlated with neurological prognosis in post cardiac arrest syndrome patients. this prospective study attempts to see the role of serum ngal as a prognostic factor by including a sufficient number of patients.

Eligibility criteria:
inclusion criteria: * adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest. exclusion criteria: * patients who did not survived 3 days after cardiac arrest. * pre-existing end-stage renal disease or dependence on renal replacement therapy
on the cyberknife dose fraction of liver cancer treatment

Conditions: CyberKnife Radiosurgery

Summary: the research aims to the primary hepatic carcinoma patients whose diameter of the single tumor is equal or less than 5cm.by supervising the changes of liver function, child-pugh score, icg-r15 value, secondary reaction, incidence rate of rild during and after the radiotherapy, meanwhile combining the outcome of the progression of disease and the condition of survival quality, the optimum proposal could be obtained and apply to clinic thus make the treatment safe, effective and personalized.


Eligibility criteria:
inclusion criteria: * the participants are from 30 to 80 years of age, without gender restriction * with the hepatopathy background, the diagnosis of primary hepatic carcinoma is confirmed by image examination and laboratory test(the diagnosis criteria is according to the primary hepatic carcinoma rule of diagnosis and treat in 2007) * the max diameter of single tumor ≤5cm * child-pugh classification(cpc) a or b * ecog score 0 or 1 * leukocyte is more than 2×109/l and thrombocyte is more than 60×109/l * kidney function is normal * unsuitable or rejecting other therapies such as resection, liver transplantation etc * anticipated lifetime is longer than six months * the participants who are voluntary comply with the requirements of research * the participants agree to sign the informed consent. exclusion criteria: * the metastasis occur outside of liver * child-pugh classification(cpc) * the outline of tumor is not confirmed by image examination * with hepatic or any other abdomen radiotherapy history before * with severe internal medicine diseases * bone marrow haematopoietic function or kidney function is severe failure * intractable ascites * the position of tumor is nearby esophagus, stomach or intestine * the normal liver volume less than 700 cm3

Keywords: cyberknife hepatocellular dose fraction icg r15
switching from preserved to preserved-free treatments for glaucoma.

Conditions: Glaucoma

Summary: a 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.

the study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12. at baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. the following examinations will be done in the following sequence: anterior segment examination, shirmer test, break-up time test. thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. finally, contact measurements will be done in the following order: iop (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). a 15 minutes interval will elapse between two consecutive tests.

Eligibility criteria:
inclusion criteria: * the patient is suffering from ocular hypertension, poag, pex, ntg. glaucoma definition is based on the european glaucoma society guidelines. * the patient is newly-diagnosed * no fluorescein staining at baseline and no observable signs of ocular surface disease * no treatment with topical bak-containing products for at least 6 months * treatment of naïve patients exclusion criteria: * unwilling to sign informed consent * not at least 18 years old * ocular condition that are of safety concern and that can interfere with the study results * closed/barely open anterior chamber angles or history of acute angle closure. * ocular surgery or argon laser trabeculoplasty within the last year. ocular inflammation/infection occurring within three months prior to pre-trial visit. * presence of the following ocular conditions: kcs, moderate-severe blepharitis, rosacea, sjogren syndrome, pterygium, contact lens users. * use of concomitant topical ocular medication that can interfere with study medication * hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. * any corneal pathology * diabetes at any stage * other abnormal condition or symptom preventing the patient from entering the trial, according to the investigator's judgement. * refractive surgery patients * women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing. * inability to adhere to treatment/visit plan. * have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).

Keywords: glaucoma intraocular pressure ocular surface benzalkonium chloride
the therapeutic role of intravenous albumin administration for peptic ulcer bleeding patients with hypoalbuminemia

Conditions: Peptic Ulcer Bleeding; Hypoalbuminemia

Summary: to test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.

peptic ulcer bleeding is a common but potentially lethal disease. recurrent bleeding is an independent risk factor for mortality. inhibition of gastric acid secretion by intravenous proton pump inhibitor infusion can have a positive impact on the prevention of ulcer rebleeding after successful endoscopic therapy. however, the rebleeding rate can still be high in patients with comorbid illnesses even after proton pump inhibitor usage. hypoalbuminemia has been reported to be a significant predictor of poor prognosis in patients with comorbid illnesses. low serum albumin levels are associated with poor prognosis of wound healing and peptic ulcer bleeding; therefore, it is worthy to conduct a head-to-head comparison to validate whether administration of albumin can be helpful in improving the control of bleeding peptic ulcers, especially in patients with comorbid illnesses. the albumin level may reflect upstream pathologic processes, such as stress or co-morbidities. albumin administration may interrupt the downstream chain of poor outcome and thus maintain a favorable homeostasis in critically ill patients, and reduce morbidity. however, the clinical benefit of controlling peptic ulcer bleeding with exogenous albumin remains uncertain, and thus administration of albumin is not widely applied. accordingly, the investigators conducted this pilot intervention to test whether short-term exogenous albumin administration can improve the control of peptic ulcer bleeding in hypoalbuminemic patients, who are at high risk of recurrent bleeding.

Eligibility criteria:
inclusion criteria: * clinical presentations of melena, hematochezia, or hematemesis * gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage * a rockal score ≥ 6 exclusion criteria: * gastric or esophageal, or duodenal tumor bleeding * ulcer due to mechanical factors * warfarin use * failure to establish hemostasis under gastroscopy * hypersensitivity to omeprazole, esomeprazole, albumin or any component of the formulation.

Keywords: hypoalbuminemia peptic ulcer rebleeding hospitalization
comparative study to examine whether echocardiography performed during cardiac resynchronization therapy device implantation can improve the response rate

Conditions: Heart Failure; Cardiac Resynchronization Therapy; Echocardiography

Summary: empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. the response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. this study tested the hypothesis that echocardiography to assess acute resynchronization of the left ventricle during device implantation may improve the response rate to the therapy.


Eligibility criteria:
inclusion criteria: 1. patients with sr or af, indicated for crt procedures (nyha class iii or ambulatory class iv despite optimal medical therapy, qrsd≥120ms and lvef≤35%) 2. patients with ischaemic or non-ischaemic cardiomyopathy can be recruited exclusion criteria: 1. patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement 2. patients who aged less than 18 or over 80. 3. patients who are pregnant. 4. patients who cannot give informed consent. 5. patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up. 6. patients who have comorbid congenital heart disease. 7. patients who have severe valvular heart disease, apart from severe mitral regurgitation. 8. patients who have unstable angina or who are within 1 month of myocardial infarction. 9. patients who have severe lung disease and accurate clinical assessment for heart failure symptoms cannot be performed. 10. patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment, crt procedures or follow-up.